Home NDC 50844-375 Anti-diarrheal
Product NDC 50844-375
11-digit product format 508440375
Labeler code 50844
Product ID 50844-375_132bccda-cebc-4c3f-a6df-0ea613564a93
Type HUMAN OTC DRUG
Nonproprietary name Loperamide HCl
Dosage form TABLET
Route ORAL
Labeler L.N.K. International, Inc.
Application ANDA076497
Marketing category ANDA
Marketing start 2005-05-03
Substance LOPERAMIDE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076497-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Anti-diarrheal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOPERAMIDE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 77TI35393C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 978010 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOPERAMIDE HYDROCHLORIDE ACTIVE INGREDIENT 77TI35393C ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 LOPERAMIDE ACTIVE MOIETY 6X9OC3H4II ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-375 ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] 22 Current NDC, Legacy NDC, 8 package rows 20240727_e34f5bbc-e43c-a69e-e94d-ebc319518204.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 2 · 35 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50844-375-02 50844037502 3 BLISTER PACK in 1 CARTON (50844-375-02) / 4 TABLET in 1 BLISTER PACK 3 blister pack 2005-05-03 0000-00-00 No No Current 50844-375-08 50844037508 4 BLISTER PACK in 1 CARTON (50844-375-08) / 6 TABLET in 1 BLISTER PACK 4 blister pack 2005-05-03 0000-00-00 No No Current 50844-375-45 50844037545 1 BLISTER PACK in 1 CARTON (50844-375-45) / 6 TABLET in 1 BLISTER PACK 1 blister pack 2005-05-03 0000-00-00 No No Current 50844-375-95 50844037595 2 BLISTER PACK in 1 CARTON (50844-375-95) / 6 TABLET in 1 BLISTER PACK 2 blister pack 2005-05-03 0000-00-00 No No Current